Global Regulatory Affairs Coordinator

7 days ago


Dublin, Dublin City, Ireland Cpl Healthcare Full time

Cpl Healthcare is pleased to partner with Thornshaw Scientific to offer a challenging and rewarding career opportunity for a Global Regulatory Affairs Coordinator. As a key member of the Regulatory Affairs team, you will be responsible for managing EU marketing authorisation dossiers and submissions, preparing and filing EU submissions, and communicating effectively with European Regulatory Authorities.

The successful candidate will possess a Life Science qualification and 2-3 years of experience in Regulatory Affairs, particularly good knowledge of EU procedures (DCP, MRP). They should be able to multi-task, communicate with colleagues in global countries, and work autonomously. For further information on the role and requirements, please refer to the job specification.

Responsibilities:

  • Manage EU marketing authorisation dossiers and submissions (MAAs, lifecycle activities, variations, transfer etc.) for our current portfolio of pharmaceutical products.
  • Prepare and file the EU submissions including life-cycle maintenance variations, initial MAA filing, labelling updates, renewals, marketing authorisation transfers.
  • Write the local modules (ex: module 1) and administrative documents.
  • Compile regulatory documentation received from other departments (CMC, clinical) for DCP, MRP and national applications in line with assigned timelines (including responses to questions).
  • Effective high-quality communication with European Regulatory Authorities, participate in meetings with health authorities as needed. Follow-up of the submissions with HA.

Requirements:

  • Life Science qualification.
  • 2-3 years of experience in Regulatory Affairs, particularly good knowledge of EU procedures (DCP, MRP).
  • Ability to multi-task.
  • Ability to communicate with colleagues in global countries.
  • Autonomy, multi-tasking abilities.


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